Kornimate/medical-research-clean huggingface dataset:
neurofeedback & alcohol dependence

Conditions: Alcohol Dependence

Summary: the study aims to examine whether the neurofeedback method (based on functional magnetic resonance imaging \[fmri\]) can help patients with alcohol dependence to control their urges to drink alcohol and thus to remain abstinent. potential effects of neurofeedback on abstinence and drinking behaviour will be evaluated based on the comparison between a group of patients receiving multiple sessions of neurofeedback training and a group of patients receiving treatment as usual over the same period of time.

neurofeedback is a non-invasive neuroscientific tool in which participants receive real-time feedback about their brain activity while undergoing functional magnetic resonance imaging. previous research has shown that participants can successfully use the feedback to self-regulate their brain responses. in this study patients who have successfully completed a detoxification programme will be trained to down-regulate/upregulate responses of motivational brain regions that are activated during exposure to alcohol/life goal-related stimuli (pictures of alcoholic drinks/life goals related). the investigators hypothesise that learning to self-regulate these neural responses will enable patients to better control craving responses to environmental alcohol cues after detoxification treatment. patients in the intervention group will undergo 6 neurofeedback training sessions, spread across 4 months. outcomes of the training will be compared with a group of patients who will not do the neurofeedback training but receive standard treatment (e.g. support groups and medication).

Eligibility criteria:
inclusion criteria: * successful completion of detoxification programme within a time window of 1 to 6 months before the recruitment * abstinence since detoxification treatment exclusion criteria: * ongoing regular abuse of illicit substances except cannabis * history of psychotic disorders not related to alcohol * iq \< 70 * involvement in other interventional research in the past 6 months * mri counter-indications, e.g. claustrophobia, pregnancy, active medical implants, passive implants deemed unsuitable, metallic dust in the eyes, certain types of metal prostheses, surgical clips, previous experience with metalworking without eye protection

Keywords: craving cue reactivity neurofeedback
evaluation of peer specialists on va pacts

Conditions: Mental Illness; Physical Illness

Summary: in august 2014, the white house issued an executive action mandating that 25 va medical centers place peer specialists (veterans recovered from mental illness who are trained to support other veterans with mental illness) on primary care teams. research shows that the success of adding new staff to existing teams can be improved by outside aid and facilitation. this quality improvement project will evaluate whether providing expanded support to half of the primary care teams will lead to better outcomes when compared with teams that do not get extra support.

peer specialists are individuals with mental illness currently deployed to serve veterans in specialty mental health clinics based upon their lived experiences. peer specialist delivered interventions have been shown to improve patient activation in multiple studies. in august 2014, the white house issued an executive action mandating that 25 va medical centers pilot the deployment of peer specialists in their patient aligned care teams (pacts). this project expands upon this nationally mandated peer specialist pilot with the integration of a cluster randomized implementation trial. this quality improvement project will evaluate the impact of facilitated implementation vs. standard implementation to support on the deployment of peer specialists in pacts. the 25 sites will be divided into three cohorts (n=8,8,9). each cohort will begin over three successive six-month blocks beginning in early 2016. within each cohort, sites will be randomized to receive either facilitated or standard implementation. facilitated implementation sites will receive one year of support based on the i-parihs implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. standard implementation sites will receive written guidance and limited consultation by the investigators' team. the investigators will compare the groups on 1) the percent of their target population that actually received ps services; 2) ratings on ps workload productivity including ; 3) peer implementation and services scores; 4) assessment of veteran's change over time on the outcome variables of satisfaction, activation, and functioning ; 5) qualitative analysis of how well pss were deployed and their impact.

Eligibility criteria:
inclusion criteria: * included sites must be va pact primary care health teams with existing peer specialists who are able to include an existing peer specialist on their team for a minimum of 10 hours per week for one year exclusion criteria: * non va pact teams, va sites without an existing peer specialists, and va pact primary care teams that cannot commit a peer specialist to primary care for a minimum of 10 hours per week are excluded

Keywords: veterans veterans health patient compliance primary health care health care providers health promotion
phase ii image guided stereotactic ablative radiotherapy for non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this study will help researchers learn about the best dose of radiation to be used when treating large early stage non-small cell lung cancer (nsclc) with a treatment called stereotactic ablative radiotherapy (sabr). current treatments with sabr for early stage nsclc show positive response. but, for large early stage nsclc it may be better to give different sabr doses than what is used in routine early stage nsclc treatment. it is not understood which dose is best for treating large early stage nsclc. therefore, this study can help researchers learn if giving a higher dose using sabr over a period of 5-10 treatment days can increase the chance of cure for large early stage nsclc.

treatment plan: 7.5 gy x 10 daily fractions delivered with volumetric modulated arc therapy (vmat) or regular intensity-modulated radiation therapy (imrt). * optional schedule of 12 gy x 5 daily fractions can may also be used only in situations where dose constraints for organs at risk can be easily met while optimal planning target volume (ptv) coverage is achieved; but the 7.5 gy x 10 daily fractions schedule is preferred. * all doses are prescribed to the tumor periphery. for this protocol, patients will be followed only up to 2 years post radiation therapy.

Eligibility criteria:
inclusion criteria: * non-small cell lung cancer * t2n0m0 or t3(pl3)n0m0 or locally recurrent ≤ 7 cm * surgically inoperable * ecog performance 0-2 exclusion criteria: * pacemaker on the same side of the tumor * pregnant * infection that requires iv antibiotics * concomitant or adjuvant anti-neoplastic chemotherapy

Keywords: non small cell lung cancer surgically inoperable radiation therapy
diagnostic value of flexible spectral imaging color enhancement (fice) plus probe-based confocal laser endomicroscopy (pcle) for minimal change esophageal reflux disease (merd) diagnosis

Conditions: Gastroesophageal Reflux Disease

Summary: gastroesophageal reflux disease (gerd) patients without obvious mucosal break by endoscopy were examined by fice, followed by confocal. validity scores for merd diagnosis were analyzed.

thirty-six patients with suspected merd (positive gerdq but normal conventional endoscopy) and eighteen asymptomatic control were recruited. the new fice (epx-4450hd) was performed at non-magnified, x50, and x100 zoom levels. the criteria for positive fice were; a) triangular indentation, b) punctuate erythema, c) villiform mucosa, or d) increased number of capillary vessel. at the same session, pcle was applied to count the number of intrapapillary capillary loops (ipcls) by using more than 5 ipcls in 500x500 micron area as a criterion for merd diagnosis. the validity scores of both modalities and interobserever agreement of pcle interpretation was assessed.

Eligibility criteria:
inclusion criteria: 1. age more than 18 year old 2. no ppi therapy in previous 2 weeks and 3. no esophageal tumor or stenosis or history of esophageal surgery. exclusion criteria: 1. bleeding tendency including decompensated cirrhosis, chronic kidney disease 2. long term antiplatelets or anticoagulants, 3. pregnancy or 4. history of fluorescein allergy.

Keywords: diagnostic technique and procedure
active surveillance of the small renal mass

Conditions: Small Renal Mass, Kidney Cancer

Summary: active surveillance in kidney cancer involves closely observing the tumor with periodic imaging studies rather than immediately proceeding to an invasive treatment. this does not mean that the tumor is ignored or that future treatment is not necessary, rather it means the tumor does not require treatment at this time. on active surveillance, a tumor is closely monitored without treatment, however if the tumor changes and reaches a predefined threshold that your physician no longer considers safe, your physician will strongly encourage treatment.

while some patients with small kidney tumors may require eventual treatment, most do not. therefore, the american urologic association considers active surveillance an acceptable treatment strategy. this protocol is a prospective study of active surveillance for small clear cell kidney tumors (the most common type of kidney tumor) and is designed to identify if there are predictive markers that may help identify which patients are unlikely to require surgical treatment. predictive markers are measurable characteristics that may predict the future behavior of a tumor. there are currently no available predictive markers that can help identify which tumors are not destined to require treatment. such a marker may be useful to increase the use of active surveillance by informing patients with small renal tumors that immediate treatment may be considered overtreatment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * life expectancy \>3 years (by physician estimate) * measurable, solid renal neoplasm, 1.0 -2.7 cm in size and visible on ultrasound * clear cell renal cell carcinoma histology * renal tumor diagnosed within 6 months * recent biopsy (\<6 weeks) performed, if performed at an outside institution, there must be sufficient material for biomarker analysis * no evidence of vascular invasion or regional nodal/distant disease * renal tumor that is able to be managed with upfront surgery * adequate organ function (hemoglobin \> 9, absolute neutrophil count (anc) ≥ 1500/μl platelets ≥ 100,000/μl, ast and alt ≤3.0 upper limit of normal (uln), total bilirubin ≤ uln, egfr ≥ 30 * good performance status (ecog ≤2) * understanding and willingness to provide consent exclusion criteria: * history of a hereditary renal cancer syndrome * tumor \>2.7 cm, stages t1b-t4 * life expectancy \<3 years * presence of an active, untreated, metastatic non-renal malignancy * uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months that would predispose to immediate surgical therapy * medical contraindication to upfront surgical management of renal mass * history of bleeding diathesis or recent bleeding episode that would prevent surgical resection * unwillingness to undergo monitoring and imaging studies

Keywords: tumor growth rate in maximal dimension, biomarker assessment based on driver gene alterations (specifically crg)
treatment of igan with multi-glycoside of tripterygium wilfordii hook. f.

Conditions: IgA Nephropathy

Summary: the purpose of this study is to determine whether multi-glycoside of tripterygium wilfordii hook. f. is effective and safe in the treatment of iga nephropathy.

primary iga nephropathy (igan) is the most common form of idiopathic glomerulonephritis throughout of the world. the disease is characterized by the predominant deposition of polymer gal-deﬁcient iga1 immune complex（pgd-iga1-ic）in the glomeruli which leads to the proliferation of mesangial cells. mycophenolate mofetil is reported to be useful in the treatment of igan in chinese patients, but the price is expensive together with some adverse events. tripterygium wilfordii hook. f. is a traditional chinese medicine and is useful in the treatment of ckd, the purpose of this study is to determine whether multi-glycoside of tripterygium wilfordii hook. f. is effective and safe in the treatment of iga nephropathy

Eligibility criteria:
inclusion criteria: * urinary protein levels ≥1.0 g/24 h * estimated glomerular filtration rate (egfr) ≥30 ml·min-1·1.73 m-2body surface area by the mdrd formula (egfr=194×age-0.287×serum creatinine * 1.094(×0.739, if female) (where scr is the serum creatinine, dry chemistry method, mg/dl)) * peripheral blood white blood cell count ≥3000×109/l * no other cause for tubulointerstitial lesions * no history of immunomodulatory agent intake before renal biopsy * no systemic infection * age between 16 and 65 years exclusion criteria: * severe infections

Keywords: tripterygium wilfordii hook. f. mycophenolate mofetil
tumor characteristics in patients with paraneoplastic neurological syndromes (pns)

Conditions: Cancer; Paraneoplastic Syndromes; Neurologic Disorder; Immune System and Related Disorders; Tumor Genetics

Summary: paraneoplastic neurological syndromes (pns) are immune-mediated complications of cancer that can affect any part of the central or peripheral nervous system. pns occurs at the intersection between immune system and the tumor, where a combination of genetical and environmental factors may play a role. mechanisms leading to immune tolerance breakdown and autoimmunity in pns remain largely unknown, and this reflects in an unsatisfactory repertoire of treatments available. moreover, a better understanding of the biological mechanisms underlying pns would allow a more precise identification of the modalities that permit pns patients to have a better oncological prognosis than cancer patient without pns, with obvious repercussions in clinical oncology. to this effect, an extremely innovative approach involves directly exploring the tumoral tissue of patients suffering from specific pns via genomic and transcriptomic analysis. the study team hypothesizes that antigen ectopic expression by tumour cells may contribute to the generation of pns. in the present study, the investigators will analyze the salient features of tumors associated with pns, namely the histological and immune cells infiltrate characteristics, their transcriptomic profile, and mutational status of involved antigens.


Eligibility criteria:
inclusion criteria: * presence of well characterized antibodies in serum or cerebrospinal fluid; * histologically proven cancer with available tumour sample; * paraneoplastic neurological syndrome (pns) diagnosis according to the international guidelines; * age: at least 18 years old. exclusion criteria: * absence of complete clinicopathological data
development of a new diagnosis and intervention method for developmental disorders

Conditions: Developmental Disabilities

Summary: the purpose of this study is to develop a new diagnostic method for developmental disorders based on behavior recording during the interview of the subjects by medical staff as well anonymous persons. the behavior recording by video camera will be accompanied by non-invasive physiological recordings, including electroencephalogram (eeg), electrocardiogram (ecg), electromyogram (emg), and body temperature using infrared (ir) thermograph. thus, the physiologically relevant and the disorder correlated behavior parameters could be extracted and used as new diagnostic markers. if necessary, the medical staff may take blood sample from the subject before and after the interview. for the longitudinal study, the similar interview and the recording of the same subject will be planned to evaluate the effect of the medical and educational intervention. the investigators also examine the synergistic effect of the intervention and the administration of the supplement (e.g., vitamin d, arachidonic acid, coenzyme q10 (coq-10)). the clinician may use risperidone.

case 1:the investigators started the intervention and supplementation of arachidonic acid for 3 patients diagnosed as autistic spectrum disorders (asd) from september 4, 2010 at sawa hospital (osaka, japan). another asd patients (n=5) at sawa hospital were treated by administration of risperidone as medicinal drink from january 14, 2011. the supplementation as well as risperidone administration followed double-blind placebo controlled cross-over protocol to access the effect of the treatment. these trials will continue until november 2011. final outcome will be evaluated by clinical diagnosis and behavior parameters measurement as described under brief summary. case 2: the investigators started the intervention and supplementation of reduced form of coq10 for learning disability children (n=20) at small private cramming school (jizai-ken, tokyo) from february 5, 2011. this trial will continue until october 2011. the effect of the intervention and supplementation will be evaluated by behavior parameter measurement as described above.

Eligibility criteria:
inclusion criteria: * developmental disorders exclusion criteria: * mental retardation

Keywords: autistic spectrum disorders developmental disorders
ablation at virtual-heart predicted targets for vt

Conditions: Ventricular Tachycardia; Ischemic Cardiomyopathy

Summary: the goal of this study is to test the efficacy of the new imaging/simulation ("virtual heart") approach for determining the optimal ablation sites in patients with vt, which render post-infarction vt non-inducible. the study will test both the acute outcome of the ablation procedure, and the effect the use of the predicted targets has upon procedure time.


Eligibility criteria:
inclusion criteria: * eligible patients must be at least 18 years old at the time of enrollment. * a pre-op cardiac mri including late gadolinium enhancement (lge) must be performed prior to ablation. as johns hopkins university (jhu) performs mris with implantable cardioverter defibrillator (icd) or pacemaker implanted, patients with these devices may be enrolled. * eligible patients must suffer from vt, thought to be secondary to structural heart disease (scarring). * eligible patients must be determined to be suitable candidates for ablation to treat vt by their cardiologist and/or electrophysiologists regardless of this protocol. exclusion criteria: * patients with glomerular filtration rate (gfr) \< 30 ml/min should not be enrolled in the study due to the use of intravenous gadolinium as an mri contrast agent * if a pre-procedure mri cannot or likely will not be performed for any reason (such as claustrophobia), the patient must be excluded. * pregnant women may not participate in the study because gadolinium mri contrast is contraindicated in these patients. * any subject that, during the course of the pre-procedure imaging, is discovered to have vt not related to scarring, he/she must be de-enrolled from the study.
alendronate in the prevention of collapse of femoral head in non-traumatic osteonecrosis

Conditions: Non-Traumatic Osteonecrosis

Summary: to determine the cumulative incidence of total hip replacement, time to event after treatment with fosamax or placebo during the study peroid

to determine the cumulative incidence of total hip replacement and collpase of femoral head, time to event after treatment with fosamax or placebo during the study peroid

Eligibility criteria:
inclusion criteria: * osteonecrosis of femoral head * be able to provide singed informed consent exclusion criteria: * prior bisphosphonate use * pregnant or lactating woman * bilateral hip replacement

Keywords: osteonecrosis total hip replacement
long-term study of ts-142 in patients with insomnia

Conditions: Patients with Insomnia

Summary: this is a randomized, open-label, multi-center long-term study in patients with insomnia.


Eligibility criteria:
inclusion criteria: 1. japanese male and female who are aged 18 years or older at the time of informed consent 2. outpatients 3. patients falling under the category of insomnia disorder according to the diagnostic criteria in the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) other protocol defined inclusion criteria could apply. exclusion criteria: 1. patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in dsm-5 2. patients with psychiatric diseases other than depression and anxiety 3. patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep other protocol defined exclusion criteria could apply.
feasibility pilot exploring variability in biomarkers and pros in aml

Conditions: Acute Myeloid Leukemia (AML)

Summary: this research study is being conducted to help understand how the symptoms during treatment for acute myeloid leukemia (aml) may be affected by metabolism and how best to study this association. symptoms include experiences like fatigue, sleep disturbance, pain, and depression.

this is a prospective, longitudinal, observational exploratory study. ten participants will be enrolled and will complete baseline and week 4 blood sample collections. symptom questionnaires will be completed at baseline, 1-, 2-, 3- and 4-weeks. this research study is a pilot study, which means it is the first time that researchers are studying the associations between symptoms and metabolism in this way. the national institute of nursing research is supporting this research study by providing funding for the research study.

Eligibility criteria:
inclusion criteria: * the cantor center crc will attend weekly protocol meetings in the dfci adult leukemia center to identify eligible patients and will confirm eligibility by reviewing the electronic health record and, if needed, contacting the treating physician. subjects enrolled in clinical trials or other studies requiring extra blood samples and/or completion of questionnaires will be discussed with their oncology care team and/or investigators of the other study teams to ensure avoidance of excess subject burden. only subjects deemed appropriate for enrollment without adding excess burden will be approached about this study. * inclusion criteria: * adult (18+ years old) * new diagnosis of acute myeloid leukemia (aml) * admitted to the dfci inpatient hospital in the bwh for intensive induction chemotherapy (e.g., 7+3 regimen) * eastern cooperative oncology group scale of performance status (ecog ps) ≤ 3 or karnofsky performance status (kps) ≥ 50 * ability to comprehend and speak english * ability to provide informed consent exclusion criteria: * cognitive or psychiatric conditions prohibiting study consent or participation * multiple primary cancers * a treating clinician reports that the subject is inappropriate for the study or that the study presents excess subject burden

Keywords: acute myeloid leukemia (aml)